SOCRA - Society of Clinical Research Associates The Informed Consent Process Questions and Answers 2

Question 1

What are the eight required consent elements under 21 CFR 50.25(a)?

Accepted Answer

Purpose/procedures, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation

Answer

The eight elements: research description, risks, benefits, alternatives, confidentiality, injury compensation, contacts, voluntary participation.

Question 2

What additional consent elements under 21 CFR 50.25(b)?

Accepted Answer

Unforeseeable risks, termination circumstances, additional costs, withdrawal consequences, new findings, and number of subjects

Answer

Six additional elements: unforeseeable risks, termination, costs, withdrawal consequences, new findings, and number of subjects.

Question 3

How should consent be obtained from non-English speakers?

Accepted Answer

Certified translation or short form with witness and interpreter per 21 CFR 50.27

Answer

Either a certified translation of the full form or a short form in their language with a witness.

Question 4

When is re-consent required?

Accepted Answer

When significant new information arises that may affect willingness to continue

Answer

Required when new information could affect willingness, including safety findings, protocol amendments, or risk/benefit changes.

Question 5

How should the consent process be documented?

Accepted Answer

A note documenting who obtained consent, that adequate time was given, and consent was voluntary

Answer

Best practice: document who conducted the discussion, that questions were answered, and consent was voluntary.

(SOCRA) Society of Clinical Research Associates Practice Test